Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:37 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT00595868
Description: Since this is a marketed drug we did not enter data about expected non-serious AEs into our database. The 0 non-serious AEs does not imply that no AEs were \>5%, only that we did not capture that for analysis.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) collected for 1 month after last dose of study medication, which varied from 2 weeks to 5 months
Study: NCT00595868
Study Brief: Efficacy of Varenicline in Ambivalent Smokers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Varenicline 2 milligrams varenicline once per day for 2-8 weeks None None 0 107 0 0 View
Placebo Placebo once per day for 2-8 weeks None None 0 111 0 0 View
Serious Events(If Any):
Other Events(If Any):